Comparing Dopamine and Norepinephrine for Low Blood Pressure in Very Preterm Infants with Sepsis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness of Dopamine versus Norepinephrine in treating fluid-unresponsive hypotension in very preterm infants suspected of having late-onset sepsis. Utilizing real-world data from the Canadian Neonatal Network, the study will analyze treatment outcomes from a large patient registry across multiple hospitals. By standardizing treatment strategies and employing a comparative effectiveness research framework, the study seeks to provide insights into the relative safety and efficacy of these commonly used medications in a vulnerable population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ≤32 weeks gestational age and \> 48 hours of life
* Receiving primary vasopressor therapy with Dopamine or Norepinephrine in the context of suspected late-onset sepsis or necrotizing enterocolitis with systemic hypotension (defined as: culture positive or negative bloodstream infection)

Exclusion Criteria:

* Known chromosomal or genetic anomalies
* Receiving primary therapy with agents other than Dopamine or Norepinephrine

Where it's running

• Dayton Children's Hospital
  Dayton, Ohio, United States Recruiting
• Methodist Healthcare
  San Antonio, Texas, United States Recruiting
• Foothill's Medical Centre
  Calgary, Alberta, Canada Recruiting
• BC Women's Hospital
  Vancouver, British Columbia, Canada Recruiting
• Victoria General Hospital
  Victoria, British Columbia, Canada Recruiting
• Winnipeg Health Sciences Centre
  Winnipeg, Manitoba, Canada Recruiting

Study contacts

• Principal investigator: Amish Jain, MBBS, MRCPCH, PhD — Mount Sinai Hospital, Canada
• Study coordinator: Amish Jain, MBBS, MRCPCH, PhD
• Email: amish.jain@sinaihealth.ca
• Phone: 416-586-4800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.